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June 04, 2014

Guest Post: Myriad -- An Obvious and Patent-Friendly Interpretation

Is Myriad truly authority for the proposition that naturally occurring nucleic acid sequences and a host of other naturally occurring materials are no longer patent-eligible? Was it really the intention of the Supreme Court to strip away by a side wind protection for future small molecule innovations of the stature of adrenalin (US 730,176; Parke-Davis v Mulford, 189 F. 95, 103 (1911)), digitalis (US 1,898,199), vitamin B12 (US 2,563,794; Merck v. Olin Mathieson, 253 F.3d 156 (4th Circ. 1958)), vinblastine (US 3,097,137), doxorubicin (US 3,590,028) and rapamycin (US 3,929,992 and 3,993,749)? According to natural product eligibility guidance issued by the USPTO on 4 March 2014 the answer is "yes" and for a naturally occurring composition of matter the only difference that counts is a marked difference in structure, for example that between a eukaryotic gene and its corresponding cDNA. That guidance has resulted in a storm of protest both from industry and within the profession.

The Office remains open for comments until the end of the month, and it is therefore timely to enquire whether Myriad and earlier opinions support the dramatic legal changes alleged.

To paraphrase the recent opinion in Nautilus v Biosig, a rule of law derivable from an opinion should be precise enough to afford clear notice of what is intended, otherwise there would be a zone of uncertainty: in this instance for inventors, the Office, and the public. For that reason, and also because Justice Thomas majored in English literature, the words in which the opinion of the Court is summarized should be presumed to have been chosen with precision and close semantic attention is merited.

The opinion expresses its ruling in two key paragraphs. In his opening paragraph Justice Thomas says (emphasis added):

For the reasons that follow, we hold that a naturally occurring DNA segment is a product of nature and not patent eligible merelybecause it has been isolated . . .

and he concludes:

We merely hold that genes and the information they encode are not patent eligible under §101 simplybecause they have been isolated from the surrounding genetic material.

The relevant sense of mere, according to the Merriam-Webster online dictionary, is "nothing more than", as in "a mere mortal", "a mere hint of spice" or "the mere idea of your traveling alone to Europe". The word simply in its relevant sense is synonymous with merely, also signifying "nothing more than" as in "eats simply to keep alive". The primary meaning of because is "for the reason that" as in "rested because he was tired". The words of limitation in the ruling are unmistakable, as also is the link between eligibility and supporting reasons.

Accordingly there is an arguable hypothesis that the rule of law excludes eligibility for a genetic sequence where the only reason available to support patentability is isolation from the natural environment. It does not exclude eligibility for a naturally occurring sequence where there are additional reasons supporting eligibility, e.g., new utility. Indeed, if the proposition is generalized, it amounts to no more than that a difference unaccompanied by anything more such as new function or new utility does not suffice for patentability. That proposition has been part of US law for two centuries, although it is is normally now stated in the context of § 103 rather than § 101. It also forms part of European law in the context of problem/solution analysis where technical problem is routinely reconstructed from particular technical success vis-à-vis the closest prior art.

If the hypothesis is correct, and given that a plural reason test is immediately identifiable by and obvious to arts-trained readers outside our profession, an explanation is needed why it is not yet widely accepted as the rule of law handed down in Myriad. Part of the explanation may be confusion between the factual finding and the underlying legal rule, the immediate reaction especially of scientifically trained readers being that the dividing line is between eligible cDNA and non-eligible genomic DNA. Those were the different outcomes that could be perceived in Myriad without more detailed legal analysis. Reinforcing that confusion is an expectation that Supreme Court rulings will be far-reaching and not limited and, in the case of our profession, a mindset focusing on differences rather than reasons. However, as soon as cDNA is identified as other than a product of nature it loses all relevance to the § 101 enquiry: the test for eligibility for something that is a product of nature cannot be equated either with the test for eligibility of something that is other than a product of nature or with the test whether or not a composition of matter falls within the definition of a product of nature.

It remains to ascertain whether the plural reason test is consistent with other key opinions on product of nature eligibility.

Hartranft v. Wiegmann, 121 U.S. 609, 615 (1887), is the oldest of the opinions cited in Myriad and was a Supreme Court case concerning liability to import duty rather than patents. It nevertheless contains illustrative findings that support the plural reason test:

• The application of labor to an article either by hand or by machine does not necessarily make that article a manufactured article within the meaning of the tariff laws. Blocks of marble cut to convenient size for transport are not regarded as manufactured.

• Cleaning or decontaminating a product also does not necessarily produce a new manufacture. Washing and scouring wool does not make the resulting wool a manufacture of wool. Cleaning and ginning cotton does not make the resulting cotton a manufacture of cotton. In the present case ornamental shells that have been cleaned to remove the epidermis and then polished on an emery wheel to expose the pearly interior remain shells and have not been manufactured into a new and different article having a distinctive name, character, or use from that of a shell.

• Packaging does not necessarily create a new manufacture. Hay pressed into bales ready for market is not a manufactured article, though labor has been involved in cutting and drying the grass and baling the hay.

• Even a change in physical form does not necessarily create a new manufacture. Round copper plates turned up and raised at the edges from four to five inches by the application of labor to fit them for subsequent use in the manufacture of copper vessels, but which are still bought by the pound as copper for use in making copper vessels, were held not to be manufactured copper.

• However, India-rubber shoes, made in Brazil by simply allowing the sap of the India-rubber tree to harden upon a mold, were manufactured articles because they were capable of use in that shape as shoes, and had been put into a new form capable of use and designed to be used in such new form.

Analysis of the Hartranft findings shows that an article does not become a manufacture simply on change of form or on isolation from impurities but that, consistently with the present hypothesis, such a change suffices if accompanied by the additional reason of new utility.

The plural reason test finds a paradigm example in US Patent 141,072 issued to Louis Pasteur in 1873. The problem with which Pasteur was concerned was changes in the condition of brewers' yeast, worts, and beer, and limitations on these keeping beyond a certain time. He concluded that these problems arose from microorganisms that contaminated the yeast, devised a procedure that would eliminate these contaminants, and claimed:

Yeast, free from organic germs of disease, as an article of manufacture.

The decontaminated yeast does not occur in nature and is markedly different from naturally occurring yeast which has harmful contaminant organisms. The composition has the new name, germ-free yeast. It has new characteristics because it does not contain other potentially harmful organisms. It has new utility because it can be used in brewing to create batches of beer with a reduced risk that a batch will be unusable, and the brewed beer has a better taste and longer shelf life. It therefore satisfies the Hartranft test approved in Chakrabarty and subsequently in Myriad, and it was implicitly held patent-eligible in Chakrabarty (see footnote 9).

Although it is not strictly speaking a natural product case, another example of the plural reason test may be found in Kuehmsted v. Farbenfabriken of Elberfeld Co. 179 F. 701 (7th Cir. 1910), where acetylsalicylic acid (aspirin) had previously been known but only in an impure form. The Court affirmed patentability for pure aspirin as follows:

Hoffmann has produced a medicine indisputably beneficial to mankind -- something new in a useful art, such as our patent policy was intended to promote. Kraut and his contemporaries, on the other hand, had produced only, at best, a chemical compound in an impure state. And it makes no difference, so far as patentability is concerned, that the medicine thus produced is lifted out of a mass that contained, chemically, the compound; for, though the difference between Hoffmann and Kraut be one of purification only -- strictly marking the line, however, where the one is therapeutically available and the others were therapeutically unavailable -- patentability would follow. In the one case the mass is made to yield something to the useful arts; in the other case what is yielded is chiefly interesting as a fact in chemical learning.

A further instance where isolation of a natural product to give a new form with new properties was held to give rise to patentable subject-matter involves the 1900 success of Dr. Jokichi Takamine in isolating and purifying adrenalin in fine crystalline form from the adrenal glands of sheep and oxen, for which as explained above he was granted a US Patent. The new product was said to be storage-stable when dry and when injected into an animal to bring about a rise in blood pressure. A number of product claims were granted of which the following is representative:

A substance possessing the herein described physiological characteristics and reactions of the suprarenal glands, having approximately the formula C10H15NO3 and having an alkaline reaction.

[E]ven if [Adrenalin] were merely an extracted product without change, there is no rule that such products are not patentable. Takamine was the first to make it available for any use by removing it from the other gland-tissue in which it was found, and, while it is of course possible logically to call this a purification of the principle, it became for every practical purpose a new thing commercially and therapeutically. That was a good ground for a patent.

The otherwise puzzling opinion of Justice Douglas in Funk Brothers satisfies the plural reason test, although the facts before the Court differed in some respects from those in Kuehmsted and Parke-Davis. The claim considered in that case read as follows:

An inoculant for leguminous plants comprising a plurality of selected mutually noninhibitive strains of different species of bacteria of the genus Rhizobium, said strains being unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific.

It had been known to make inoculants containing more than one strain of the different bacterial species, but these were mutually inhibitive. The only novel feature in the inoculant as claimed was that it succeeded whereas previous inoculants had not, the bacteria having gone through some process of selection that was left wholly undefined, as were the bacteria themselves. The situation was therefore the reverse of that in Myriad with new utility defined but not any supporting difference. It is not surprising in the circumstances that Justice Douglas refused to borrow invention from the discovery of the natural principle itself, but nothing more. The concurring opinion of Justice Frankfurter concluded that the particular strains by which compatibility was achieved should have been adequately identified, but this had not happened either in the claims or in the supporting description and the claimed strains were identifiable only by their compatibility. References in subsequent opinions to the bacteria in Funk being unaltered should be understood against this factual background: the bacteria in the inoculants supplied to farmers had indeed been altered by isolation, selection, and cultivation, but none of these features had been specified in any way in the subject-matter claimed.

The bacterium in Chakrabarty which was oil-digesting by virtue of additional plasmids creating new metabolic pathways was, strictly speaking, not a product of nature but was held to be a product of human ingenuity having a distinctive name, character, and use as in Hartranft. However, the reasoning here was again consistent with the plural reason test.

The opinion in Myriad is (unsurprisingly) consistent with the plural reason test if the factual situation before the Court is correctly analyzed. In his dissent in the Federal Circuit, Judge Bryson relied on Chakrabarty and held that as between what is claimed and what is found in nature the focus should be firstly on the similarity in structure and secondly on the similarity in utility. His analysis, which like that of Justice Thomas was from the standpoint of a geneticist rather than a chemist, emphasized the absence of any new utility for the isolated wild-type BRCA1 gene:

The structural differences between the claimed "isolated" genes and the corresponding portion of the native genes are irrelevant to the claim limitations, to the functioning of the genes, and to their utility in their isolated form. The use to which the genetic material can be put, i.e., determining its sequence in a clinical setting, is not a new use; it is only a consequence of possession. In order to sequence an isolated gene, each gene must function in the same manner in the laboratory as it does in the human body. Indeed, that identity of function in the isolated gene is the key to its value. The naturally occurring genetic material thus has not been altered in a way that would matter under the standard set forth in Chakrabarty. For that reason, the isolation of the naturally occurring genetic material does not make the claims to the isolated BRCA genes patent-eligible.

Justice Thomas agreed that Chakrabarty was central to the enquiry, and that qualifying subject-matter had to be a product of human ingenuity having a distinctive name, character, and use. In relation to the wild-state gene Myriad had not created anything. As previously explained, he ruled that genes and the information that they encode are not patent-eligible under § 101 simply because they had been isolated from the surrounding genetic material. In relation to genomic BRCA1 all that could be said in favor of eligibility was that it had been claimed as an isolated sequence, and that was not enough.

Isolation or purification of a naturally occurring substance leading to a non-natural composition of matter with desirable new properties has provided basis for patent grant for over a century in the US and continues to provide such basis in the UK, before the EPO, and before the patent offices of substantially every country in the industrialised world. What is remarkable about the Parke-Davis opinion is how seldom it has been challenged in the century since it was handed down notwithstanding the multiplicity of patents for naturally-occurring products of great utility and commercial value that have been granted during that time, and how widely the same logic has been adopted in other countries. It is submitted that this long standing line of authority and established practice, implicitly approved in Chakrabarty can only be overruled by clear language, and that such language is not found in Myriad or in any earlier opinion on the eligibility of products of nature.

It will be recalled that during oral argument in Myriad Justice Ginsberg expressed concern that in rejecting the patentability of isolated genomic sequences US law would be differing from that in every other industrialised nation and the US would be in a singular position. However, if the present plural reason test is accepted then much the same considerations would apply under § 101 in the US as apply under § 56 EPC in Europe, and the perceived difference would have been reduced substantially to vanishing point.

* Mr. Cole is a European Patent Attorney and Partner with Lucas & Co. in Warlingham, Surrey, UK and Visiting Professor at Bournemouth University.

Paul Cole writes: "To paraphrase the recent opinion in Nautilus v Biosig, a rule of law derivable from an opinion should be precise enough to afford clear notice of what is intended, otherwise there would be a zone of uncertainty"

As has been noted, the Supreme Court fails their own proposed test on many - if not nearly all - patent law decisions.

I think perhaps one should also see the perspective of the scientists who were asking for eligibility requirements to be made stricter. The Supreme Court probably had the intention of making the 'commons' larger so that we have less 'dominant' patents, and none based on what is found in nature. From this policy perspective the decision and USPTO guidelines make more sense.

This post is consistent with our amicus brief in Myriad where we argued that the key to understanding what Chakrabarty meant by "markedly different" is not structure but a function that is different from that in nature. Almost all new structures will have a function different from nature but isolated compounds may or may not have such a function. gDNA does not when it is used merely to obtain a person's genetic code but may be if used for treatment purposes. You can find our brief at: http://www.mcgill.ca/law/sites/mcgill.ca.law/files/gold_et_al_amicus_brief_amp_v_myriad_jan_2013_2.pdf

It is sometimes comforting to consider how well general lawyers do in the kind of skills that we have to use correctly every day.

I remember that some years ago the UK House of Lords attempted to define the tort of passing-off under UK law. There were three lead judgments, each listing five critical factors. Only three of the factors were common to all lists. So if the judges were being examined for having correctly identified the set of critical factors relevant to the tort, they would have all failed. It should be borne in mind that this was not something new, such as we are confronted with on a daily basis: the tort in question had been recognised in UK law for at least 100 years. In UK and Europe we have strict examinations to sort out those who can succeed in this kind of task and those who cannot.

@ Skeptical

There is a need for discipline in our approach to decided cases. We have enough trouble interpreting the rules of law as handed down to us by the judges: creating paraphrases does not help understanding. The rule is that the single reason of isolation will not serve, but two reasons will do, e.g. isolation + new utility will do.

I have just attended a committee meeting of an organization where some of its by-laws were recognised as being insolubly ambiguous. So the committee went on to consider the purpose of the relevant by-laws. In Myriad we do not need to do this because the rules propounded are very clear and straightforward. All we have to do is to apply them.

I hope the poster understands that the Parke-Davis applicant was able to convince the examiner to allow the claim to “Adrenalin” only by convincing the examiner that "Adrenalin" the medical product, was something different than a purified or isolated version of “adrenaline,” the hormone. In other words, the claimed "Adrenalin" was markedly different from the naturally occurring adrenaline.

My understanding is that such a claim would be just as eligible today - under the guidance - as it was back in 1911.

The whole point is that the purified adrenaline was something markedly different from what occurred naturally. The purified product was a useful medical product. The naturally occurring product was not. Judge Learned Hand completely understood the point.

I didn't know that. However my comment was about what I think might have happened. If the decision was a sort of policy one about redefining the commons it's something the Supreme Court judges could not explicitly say they did, if they did it. The reason why I say this is that here in the UK, House of Lords (now the UK Supreme Court) decisions seemed to be doing this. Pushing the system in a particular direction, and letting the Patent Office and lower courts just deal with it. Applicants will learn to live with the new USPTO eligibility guidelines and the system will readjust. Of course in the meantime uncertainty, and perhaps unfairness, unfortunately ensues.

Here in the States we have this concept called separation of powers, and it guides the proper rule of law based on the highest law of our land, the constitution.

It's a pretty important concept as it is meant to keep each branch of the government from coveting or obtaining too much power (explicitly or implicitly).

Early in our country's history there was a case that is often taught in our law schools to exemplify the power of the judiciary, and in a way, to show the separation of powers doctrine in practice, focusing on the separation between two of three branches, the executive branch and the judicial branch. That case was Marbury v. Madison, and it was a fight over a rather inconsequential political appointment to a rather inconsequential office.

Now take that fight and magnify it a thousand-fold. Take that fight and instead of the judicial branch fighting the executive branch, have the judicial branch fighting the legislative branch. Our constitution explicitly gives the legislative branch the power to write patent law. Our judicial branch is trying to write patent law. The problem is that that same judicial branch appears to be the branch deciding whether its own actions are legitimate.

Do you see the problem?

And this is not a problem over some silly little office appointment. This is a problem over a major source of power: innovation. And not just any type of innovation either. But innovation that permeates almost all art fields in the modern age.

Our system was set up such that this type of expansive-reach, intricate policy driven decision is not made by a cloistered and unanswerable few, but by a very specific branch of the government, that (in theory at least) is answerable directly to the people: Congress.

Where there is a statutory provision, separation of powers implies that any rule of law derived from a particular opinion and potentially expanding the exceptions should be construed narrowly. In particular, if there are several possible interpretations of such a legal rule, the narrowest one is the most preferable.

The point is made in submissions in advance of the 9 May USPTO forum:

- - - The task of a court in interpreting §101 is explained in the following passage from Diamond v Chakrabarty:

“Our task, rather, is the narrow one of determining what Congress meant by the words it used in the statute; once that is done, our powers are exhausted. Congress is free to amend § 101 so as to exclude from patent protection organisms produced by genetic engineering. Cf. 42 U.S.C. § 2181(a), exempting from patent protection inventions "useful solely in the utilization of special nuclear material or atomic energy in an atomic weapon." Or it may choose to craft a statute specifically designed for such living things. But, until Congress takes such action, this Court must construe the language of § 101 as it is.”

The task of the USPTO in interpreting the Mayo and Myriad decisions is similarly narrow. It is limited to making of a correct determination from those decisions of the rule(s) of law applied by the Court and then making a corresponding adjustment to examination practice (if needed). Either under-stating such rules and making too limited adjustments or gold-plating such rules and making unduly far-reaching adjustments strays outside the metes and bounds of that task." - - -

What has been said by many commentators is that the USPTO has indeed gold-plated the rule of lay derivable from Myriad.

Problem is, the hypothesis doesn't make sense doctrinally. Myriad was decided under the patent-eligible subject matter prong of Section 101. Specifically, the Court said that isolated DNA fell into one of the exceptions for patent-eligible subject matter--products of nature. The Court's rationale was that merely isolating DNA did not make it any less a product of nature. Utility is a different requirement under Section 101, and there is no evidence the Court intended to combine the two requirements into one.

I am not sure that there is any doctrine or that the Supreme Court intended to create one. As soon as it cited Hartranft and brought in tarriff cases the law entered a territory with a high degree of pragmatism where issues fell to be considered case by case.

Suppose you take the position that a change of shape suffices to make a natural product into a manufacture. You then have the problem of the copper disc moulded (I presume) with a raised rim to form it into a blank for a cooking vessel. That was held not to attract a tariff because it had insufficient new utility - the disc sold for its weight in raw copper and the raised rim add nothing to the commercial value of the disc. On the other hand pouring raw rubber into a mold and allowing it to harden into a shoe to give rise to a manufactured product because the product had a new name, new characteristics and a new utility. However, doctrinally every atom was unchanged or was changed by natural hardening in a way that was inherent to natural rubber. The dividing line was new utility - i.e. a change of shape can convert a natural product into a manufacture if sufficient new utility is created, otherwise not. In the context of the tarriff cases, it seems that the new utility has to be something that the customer is willing to pay for. Likewise an orange treated with preservative, even though it is a better product with a longer shelf-life, is still an orange because its utility (and presumably price) are that of an orange. Bringing Hartranft into the debate arguably does bring utility into the product of nature debate, and these two considerations are not isolated in the way that you suggest.

I know of no better interpretation of Myriad that both identifies a workable rule and avoids unintended consequences that the Court said in Mayo were to be avoided.

What are the metes and bounds of the judiciary being told that they are no longer permitted to use the tool of common law evolution to define what "invention" means under the then newly codified section 101 in the 1952 Act?

The word "exhausted" carries a slightly different tune then it did prior to the Act, in which Congress had acquiesced to the courts the ability to define invention with that same common law tool.

In other words, you misfire in your application of the separation of powers doctrine.

You misfire (as does the Court - other than the Chakrabarty Court which appears to be the sole Court recognizing the exhaustion imposed by Congress) by ignoring what happened to jurisprudence in 1952, that Congress 'exhausted' a certain power of the judiciary.

While what you otherwise say of the doctrine may be true, what you say is not on point to the doctrine's involvement here.

The Court CANNOT write a new rule of law (implicitly or otherwise) when it does not have the constitutional authority to do so. The Court's power of interpretation does not include the power of re-construction. Whether the Court missteps and does otherwise does NOT mean that the executive branch is free to follow that errant "rule of law" in its interpretations.

"Narrow but wrong" is still wrong.

The executive branch CANNOT use the "good soldier following orders" excuse. If there is NO "correct" interpretation, the Office is under duty to so state and under duty NOT to try to apply an incorrect interpretation. Metes and bounds indeed.

This is why a violation of the separation of powers doctrine is a serious thing, creating serious consequences.

You state that you are fully aware of the doctrine of separation of powers. Of that I remain...

There is no mileage whatsoever in trying to argue to the USPTO that a Supreme Court opinion is wrong or has no correct interpretation. We can, however, try to explain what the correct interpretation is and suggest how it should be followed. That is the most that we can realistically hope to do.

Your wider constitutional point may be right, but the USPTO is not the right forum to argue it.

Upon reflection, it appears that your last response misses the mark a bit. You have moved the goalposts (or at least the perspective of the discussion) from one of "what should the Office do in regards to the metes and bounds of its duties in response to the Supreme Court" to "what an applicant might do in response to what the Office may do."

That is a different discussion.

But nonetheless, the answer I provided may also pertain to that different discussion.

Blindly accepting even a wrong executive branch following of a wrong judicial branch view of the law offers NO chance to correct the law. Recent US jurisprudence shows that an applicant challenging the executive branch can work to make sure the law is correct. As evidence, I would submit the Taffas case for your consideration.

Separately, and for further consideration, let's say for the sake of argument that we allow the Court to have their way with patent law, changing what they will. A separate argument for constitutional violation surfaces in what the Court has provided as the law of 101: void for vagueness.

As (re)written by the Court, the law of 101 SHOULD BE determined to be void for vagueness. If the Court wishes to use its version - and continue to deny that they are actively writing the law in the first instance - how can any reasonable person claim that 101 is NOT critically vague and indeterminable as to what the law covers? Look at the seesaw battles of panel after panel at the CAFC level - one decision contradicting the next. Look at the en banc Alice decision: when the judicial body, explicitly created so as to bring order to patent law throws up their hands in disgust and says "We cannot make heads or tails of this stuff" - and "this stuff" is the mess of jurisprudence created by the Court, how can any reasonable person in the applicant's shoes know what the law of 101 covers on its face? When an applicant (and hence, the public too) must wait until the judicial process has run its course for each potential application to know whether or not the application fits under the law or not, then the law is critically - and perhaps fatally - vague.

I was disappointed, albeit not surprised that this "void for vagueness" was not an argument advanced in the Alice proceedings.

Disappointed, because the void for vagueness position is on point for the Court to consider, given that the case appears to present a pivotal moment in patent law; and not surprised, as I do not think either party to the case really wanted to go to the point that 101 as a foundation of patent law would be found void, and thus potentially bringing the entire system to a standstill.

As you may have gathered from the oral arguments, several of the Justices are seeking any option to avoid such a cataclysmic confrontation. And yet, to my view of the law, such avoidance is part and parcel of the mess that we find ourselves in.

Which brings me to another discussion point (and another metaphor). We may very well have a decision from the Court in the Alice case that further 'skirts' the issue and resolves nothing in the larger scheme of things.

Justice Breyer may find his road.

But any such road will NOT remove the vagueness that has been developed by the Court itself, and will likely lead to a road (a rule of law) that cannot be followed in the next case. Such a road so constrained as to be expressly limited to the exact facts in the immediate case will be useless for developing a rule of law for the next traveler.

And to end with another metaphor, will anyone be satisfied if the beacon of light created by the Court with a decision in Alice is immediately hid under a bushel? Or is clarity from the beacon what we all crave? Clarity, so that we can see the path forward, and not walk that path in darkness, blindly groping and bumping from one CAFC panel decision to the next?

This logic here is probably what the S Ct intended, and not the very broad interpretation embodied in the USPTO guidance document of March. One niggle. While Judge Learned Hand did indeed state the things quoted, Jonathan Harkness has persuasively noted that his statement about patentability of Adrenaline was in dicta; the case in hand was a priority dispute, and he simply missed the fact that the patent had been granted by a seasoned examiner only when the examiner was convinced it was a different molecule. Parke-Davis has indeed become cited as precedent, but Judge Sweet (in his District Court ruling in Myriad) and Jon Harkness have both noted Hand's dictum was a legal mistake. It may be good law, but it was nonetheless wrong at the time. While now ensconced in practice, this history may prove relevant, and Parke-Davis may not be the landmark it has been assumed to be. See Harkness's article: Journal of the Patent and Trademark Office Society, Vol. 93, No. 4, pp. 363-399, 2011 or through SSRN working papers site: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1881193

On the whole I think that the adrenaline case merely reinforces the aspirin case and neither of them have much to do with pine needles. Even if Learned Hand's proposition was initially doubtful, it has been followed for over 100 years, and the settled expectations of industry should not be ignored.

The point was raised in argument in Myriad, and counsel for the association expressly accepted the patentability of isolated medicament substances. The context was a discussion of "Amazonic acid", and in view of the concession it is surprising that an example written in a contrary sense appeared in the Office guidance.